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Patients Offered Sorafenib in Phase 3 Study After Interim Analysis Reveals Disease Stabilization
The companies are communicating this information to the study investigators, and it is expected that investigators will begin reaching out to participating patients. In addition, Bayer and Onyx will continue preparing a New Drug Application for possible approval in the United States. The companies will also continue discussions with regulators outside the U.S. about proceeding with a filing based on the results of this trial as amended. Sorafenib previously received Orphan Drug designation for RCC from both the U.S. FDA and the European Medicines Agency (EMEA).
"Interim data from the Phase III trial showed that patients taking sorafenib had a clinically significant improvement in the duration of disease stabilization (defined as progression-free survival). Based on these interim data and subsequent discussions with the DMC and regulatory authorities, Bayer and Onyx agreed that it was in the best interest of patients to offer sorafenib to all study participants," said Wolfgang Plischke, President of Bayer HealthCare's Global Pharmaceutical Division.
Phase III Summary
The multi-national, placebo-controlled Phase III study recently finished enrolling over 800 patients with advanced kidney cancer. Participating patients were randomized to receive either sorafenib or placebo. The primary endpoint of the study is overall survival, with progression-free survival, overall response rate, and safety also being assessed. The pivotal trial was initiated in the fourth quarter of 2003 after a Special Protocol Assessment (SPA) was completed by the FDA.
Sorafenib, a novel investigational drug candidate, has demonstrated both anti-proliferative and anti-angiogenic properties - two important anticancer activities. In preclinical models, sorafenib inhibited tumor cell proliferation by targeting the RAF/MEK/ERK signaling pathway at the level of RAF kinase. Sorafenib also exerted an antiangiogenic effect by targeting the receptor tyrosine kinases VEGFR-2 and PDGFR and their associated signaling cascades. In addition, sorafenib also inhibited other tyrosine kinases, including FLT-3 and c-KIT.
Source: Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc.